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Conference Surveillance ACTIONABLE competitive intelligence (CI) is a critical asset for pharmaceutical companies, but with more than 7,000 agents in develop- ment globally¹, the act of collecting, analyzing and gleaning actionable steps from CI can be a daunting task for commercial teams. The importance of competitive information cannot be overstated – it not only helps commercial teams acquire an in-depth knowledge of the market, the competitive landscape, and changes in the marketplace, but perhaps more importantly, CI provides the basis for teams to identify new opportunities and threats, to position and counter-position agents in development, and to construct preemptive strategies early to remain competitive at launch. Fall 2016 Conference Surveillance © Artisan Healthcare Consulting, Inc. 1

Conference Surveillance Whitepaper Fall 2016

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Page 1: Conference Surveillance Whitepaper Fall 2016

Conference Surveillance

ACTIONABLE competitive intelligence(CI) is a critical asset forpharmaceutical companies, but withmore than 7,000 agents in develop-ment globally¹, the act of collecting,analyzing and gleaning actionablesteps from CI can be a daunting taskfor commercial teams.

The importance of competitiveinformation cannot be overstated – it

not only helps commercial teamsacquire an in-depth knowledge of themarket, the competitive landscape, andchanges in the marketplace, butperhaps more importantly, CI providesthe basis for teams to identify newopportunities and threats, to positionand counter-position agents indevelopment, and to constructpreemptive strategies early to remaincompetitive at launch.

Fall 2016

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Facts. Insights. Actions.

Conferences provide attendees unparalleled access to a broad scope ofscientific and clinical development in a therapeutic area. However, it isprecisely this enormous scope of content that often overwhelms attendeesand leads to CI that is incomplete, non-standardized, and of little strategicor tactical value. Take, for example, the annual American Society ofClinical Oncology (ASCO) meeting.

There are more than 1,800 oncology agents in development globally¹; inthe United States alone, there are more than 800 oncology medicines andvaccines in either clinical trials or in under review by the US Food andDrug Administration (FDA).² Of the four major oncology conferenceshosted annually, ASCO stands out as the preeminent venue for thepresentation of clinical oncology data.

As such, ASCO 2016 had over 38,000 attendees, 5,817 submittedabstracts, 2,463 presented abstracts, 1,995 abstracts that reported clinicaltrial results, 241 live conference sessions, and hundreds of presentedposters—and attendees had only five days to access all of theinformation³. (Figure 1) When faced with such a magnitude of information,it is no surprise that many teams fall short of their CI goals for conferencesurveillance.

IntroductionIndustry conferences are one of the most important sources of information for CI

Conference Surveillance2© Artisan Healthcare Consulting, Inc.

>38,000 attendees

5,817 submitted abstracts

2,463 abstracts presented live

1,995 abstracts with clinical trial data

241 live conference sessions

5 Days

FIGURE 1

The ‘Sizable’ Challenge with Conference Surveillance: ASCO 2016 by the Numbers³

1 Pharmaceutical Research and Manufacturers of America (PhRMA). 2015 Profile, Biopharmaceutical Research Industry. http://www.phrma.org/sites/default/files/pdf/2015_phrma_profile.pdf.Accessed August 2016.

2 Pharmaceutical Research and Manufacturers of America (PhRMA). Medicines in Development For Cancer. http://phrma.org/sites/default/files/pdf/oncology-report-2015.pdf. Published 2015. Accessed August 2016.

³ ASCO 2016 Website. https://am.asco.org/2016-abstract-submission-and-session-statistics and http://iplanner.asco.org/am2016/#/. Accessed August 2016.

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Facts. Insights. Actions.

þ How can we utilize market information to best position our product or portfolio?

þ What are the key opportunities and challenges to accelerate our compound to proof-of-concept and registration?

þ What are competitors doing today that will block or limit the commercial opportunity for our therapies in development?

þ Have our competitors presented any preclinical or clinical data that demonstrates proof of mechanism or combination rationale for one of our assets?

þ Are any of our competitors employing novel trial designs or development strategies that we can learn from?

FIGURE 2

Examples of strategic and tactical questions answered by conference surveillance

While many organizations have teams that specialize in capturing CI,these teams are typically tasked to focus on branded or marketed productsduring major conferences, rather than new and emerging products. Inorder to adapt to changing trends in the market, commercial teams requiredetailed, in-depth coverage of agents in development and would benefitfrom conference surveillance that focuses on early-stage compounds.

To fill the CI gaps, some commercial teams turn to “off-the-shelf”conference surveillance reports. While “off-the-shelf” surveillance reportsdo provide an overview of major themes from a conference, these reportstypically lack the specificity of intelligence required to confidently craftstrategic or tactical plans for a targeted molecule or development portfolio.

In our work with commercial clients, we’ve developed a framework for“Conference Surveillance Best Practices”. Our framework can helppharmaceutical and biotech teams effectively prioritize and manageconference surveillance activities with the goal of bringing surveillance CIthat is actionable and that can be used to strengthen both strategic andtactical plans back to their organizations (Figure 2). Obtaining meaningfulconference CI comes down to having an organized approach with the rightresources, processes, and tools in place.

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Facts. Insights. Actions.

Conference surveillance activities are divided into three groups based onwhen the activities are completed: pre-conference, during the conference,and post-conference. A high-level timeline of activities and a full check-listof surveillance activities are presented in Figures 3 and 4, respectively;each activity group is discussed in detail in the subsequent sections.

1. Pre-conference

Pre-conference activities are crucial to successful conference surveillanceand are largely exercises in organization and prioritization, with theplanning process typically beginning six weeks before the start of theconference. Teams initiate surveillance activities by constructing a pre-conference market landscape of compounds, indications, or topics ofinterest, ideally segmented by a more granular variable (e.g., bymechanism of action). This initial list acts as a high-level reference fordetermining the priority of conference abstracts and sessions during theabstract review.The final list of abstracts typically becomes available two to three weeksbefore the start of the conference. Upon posting, the surveillance teamperforms the following tasks:

1. Download the comprehensive list of abstract titles. The total list ofabstracts may total in the thousands for large conferences. In the caseof ASCO 2016, there were 2,463 presented abstracts (Figure 1).

2. Remove any obviously out-of-scope titles.

3. With the remaining list, team members divide and read the abstracttitles to determine if the content in the title is sufficient to understandthe content of the abstract. For those titles that are not descriptiveenough, the team member reads the body of the abstract to get asense of whether or not that presentation is in scope.

4. Once the team has created a list of relevant presentations, teammembers begin to categorize and group abstracts (e.g. by MoA, tumortype) to streamline coverage and report writing.

5. The team then rates these abstracts based on relevance and interestusing a standardized scale (e.g., 1 as highest priority to 5 as lowestpriority). In the example of a 1 to 5 scale, any abstract that is not ratedin the top three will be removed.

Often, the use of this standardized process for pre-conferenceabstract review will reveal the core themes emerging from aconference before the conference begins, and these themes may hintat emerging competitive threats.

6. In order to ensure thoroughness, we advise teams to utilize theconference website search function to find abstracts with key terms ofinterest, such as specific mechanisms or therapies. Add any highpriority abstracts discovered from these searches to the final abstractlist, if they are not already included.

7. Finally, team members compile all of this information and align on thefinal list of posters and presentations that must be covered in personat the conference.

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Conference Surveillance Best Practices

Conference Surveillance4© Artisan Healthcare Consulting, Inc.

Repeat the search process several times for indications, mechanisms of interest, or emerging themes that may identify new competitive entrants. Additional searches are a critical contingency step that protect teams from being blindsided by missing important posters, topics, or trends.

Insider Best

Practice

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Facts. Insights. Actions.

Abstract Review Resourcing

Pre-conference Post-conference

Conference

- 1Weeks - 5 - 4 - 3 - 2 0- 6 + 1 + 5+ 4+ 3+ 2 + 6

Create Pre-conference

Market Landscape

Finalize Master

Schedule

Abstracts Published,Download

Finalize Abstract

List

Team Kick-off

Daily Info Capture

Design Data Template Daily team

Re-group

Distribute Short Executive Summary

Distribute Final Report with Full ES, Strategic / Tactical

Recommendations and Detailed Session Info

FIGURE 3Timeline of Conference Surveillance Activities

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Facts. Insights. Actions.

A. Pre-conferenceDevelop a master list of posters / presentations toattend.þ Six weeks prior: Create a Pre-Conference Market Landscape of

high priority compounds, indications, or topics, ideallysegmented for granularity (e.g., by MOA).

þ 2–3 weeks prior: Download final list of abstracts.þ Remove out-of-scope abstracts based on metrics defined in Pre-

Conference Market Landscape; read remaining abstracts tofurther refine list.

þ Rate remaining abstracts based on priority or interest using astandardized method (e.g., 1 to 5 scale); remove any low-priority/low-interest abstracts.

þ Repeat search for additional topics, trends, or indications ofinterest.

þ Meet with Team to align on final list of posters / presentations toattend. If necessary, review the plan with the broader team,including management.

Resource the master list of posters / presentations toattend.þ 1 week prior: Download conference center map to reference

during resourcing decisions.þ Create Master Schedule that includes date, time, and location.þ Overlay the final list of posters / presentations onto the Master

Schedule. Include arrival / departure time windows, discussiontime, and travel time for each event.

þ Assign team member(s) to each event based on topic or generaltheme.

Design the conference surveillance template.þ Define data metrics to capture during surveillance (e.g., trial

endpoints, trial cohorts, SOC changes, etc.).þ Create standard template to capture data metrics during posters

/ presentations / Q&A. Consistency in data capture is critical toallow for post-conference analysis.

þ Distribute template to team before the start of the conference.

B. Conferenceþ Day 1: Team Kick-off meeting to review and reinforce topics of

interest.þ Daily: Capture pictures of slides and posters, key presenter

points, Q&A topics, etc.þ Daily: Re-group with team at the end of every day to share

learnings and adapt / re-prioritize schedules for the next day.

C. Post-conferenceþ Post-week 1: Distribute short Executive Summary highlighting 5-

7 key themes. Include near-term data that will impact prescribingor launch plans, longer-term emerging agents with promisingdata, and key competitors that directly impact developmentstrategy.

þ Post-week 4 to 6: Distribute full conference report. Reportincludes an Executive Summary with up to 15 key findings andstrategic / tactical recommendations. Body of report includesdetail on sessions of high strategic or tactical importance.

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FIGURE 4Conference Surveillance Activity Check-list

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Facts. Insights. Actions.

With a final list in hand, the team can begin the detailed task of resourcingthe various events. Resourcing begins by first determining whether anabstract or presentation should be attended in person or whether thecontent in the abstract is sufficient. Keep in mind that efficacy and safetydata are often updated between abstract submission and the conferencesession, especially for ongoing trials. Because of this, avoid relying solelyon the content of the abstract for high priority presentations. Once thisdetermination is made, create a Master Schedule of date, time, andlocation and then overlay the presentations and posters to be covered.Constructing a realistic schedule is a tripping point for many teams; itrequires a surprising micro-level of detail to be achievable in practice.

For example, an oral session from 12pm to 2pm, with the abstract ofinterest scheduled from 12:45-12:55, should include an arrival window(e.g., 12:35 – 12:40) as well as post-session travel time (e.g., 2:05 – 2:15),assuming the attendee stays to listen to the Q&A portion. For an oralpresentation, consider adding additional time to hear the discussant of theabstract, as the discussion and ensuing Q&A provides contextualinformation as well as reality checks not included in the abstract.

Omitting buffer windows for arrival, departure, or discussant presentationswill result in over-booking team members and missing importantconference CI. Certain sessions will also be filled to capacity withoutoverflow – if team members don’t arrive early they will end up standing theentire time or missing the presentation completely.

Once the full list of abstracts is in the Master Schedule, team members areassigned specific abstracts to cover on each day. It is helpful for the sameteam member to cover abstracts with similar themes (e.g. the samemechanisms or tumor types) in order to streamline the process ofcomparing and providing context for similar presentations.

The final pre-conference activity is to construct a template to ensure thatinformation is collected in a consistent format across team members andabstracts. Outline special topics of interest for each abstract or generalthemes for each team member. Then create and distribute a template thatuses consistent feedback metrics for capturing the salient points fromposters, presentations, and Q&A. Consistency in data capture is critical toallow for post-conference analysis. As an example for Q&A, we adviseteams to capture each question raised by the audience, together with theresponse by the presenter / panel member. We also recommend that teammembers add their own perspective on whether the questions raised wereadequately addressed, or whether the question remains open. Thesequalitative comments are helpful to refer to when considering theimplications to strategy.

When creating a Master Schedule, the team must evaluate the distancebetween sessions to ensure schedule feasibility, as some venues arelarge enough where travel time between sessions can take fifteenminutes if located on opposite ends of the conference center. Werecommend downloading a conference center map to help withplanning. Considering proximity of different presentations is essential tomaximizing team coverage.

Insider Best PracticeC

Include data metrics around clinical trial design (e.g., trends in trial end-points, sample cohorts, etc.) in your template. Clinical trials serve amultitude of purposes, from the most basic need to support regulatoryapproval, to product positioning or differentiation, for reimbursement orvalue/cost-effectiveness, and increasingly as a competitive means forcompanies to outmaneuver their competition. Understanding the clinicaldevelopment strategy of a competitor is essential information to counterthe claims of a competitive trial, to accelerate your own clinical strategy,or to develop tactics to expand your product’s market opportunity in theface of competitive market entrants. By consistently capturing clinicaltrial read-outs you can answer the question, “Do we need to modify ourdevelopment program to remain competitive at launch?”

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B. During the conference

Effective surveillance during the conference is largely centered onenacting a well-constructed pre-conference plan. Without substantial pre-conference preparation, beginning weeks before the conference, the act ofsurveillance becomes ad-hoc and the end product is of limited value.

Start the conference with a team kick-off meeting to review and reinforcethe topics of interest and the key points to listen for in oral presentations.At sessions and abstracts, instruct team members to capture pictures ofslides or posters as necessary, key presenter points, and Q&A topics ofinterest. At the end of every day, meet with the team to align on keylearnings and discuss additional topics to cover for the next day.

This wrap-up meeting at the end of each day is critical to allow the team toadapt and re-prioritize schedules based on what they’re hearing indiscussions or seeing in the presented data, and functions as acontingency step to avoid missing important data.

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Packed days of conference surveillance are hectic and can feeldisorganized if team members are not prepared. Ensure team membershave a bag with the following materials each day of the conference:1) a print out of the conference center floor plan, especially for large

conferences such as ASCO and the American Association for CancerResearch (AACR). Alternatively, some conferences have apps thatteam members can download with interactive conference center maps,

2) a printed list of presentation details including abstract title, date, time,and room number as well as the team member assigned to cover each,

3) a digital camera and charger to capture pictures of the presentationsand posters,

4) a phone and phone charger to communicate last minute schedulechanges to fellow team members, and

5) a computer with the saved note-taking templates so team memberscan take notes during each session.

Insider Best PracticeCBe sure to make a note of how ‘full’ a session is, as this will give you aquick indication of topic importance. Also be sure to monitor social mediaand notable pharma blogs in the weeks leading up to the conference todetermine the sessions that will likely be well-attended. Keep in mind thatthese sessions will often fill up early, so if a session is of high importance tothe team’s CI, send a team member to the session early to ensure a seatbefore the room reaches capacity.

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Facts. Insights. Actions.

C. Post-conference

Post-conference activities include summarizing and reporting the findingsand turning these findings into actionable recommendations for theorganization. CI that delivers predictive information that helps companiesanticipate market disruptions, and that can be acted upon to developcounter strategies and tactics, is the most useful to commercial teams.This information should be delivered in a timely manner, as the insightsmay become quickly outdated, especially in dynamic markets.

Within one week, assemble a short Executive Summary of five to sevenkey insights from the conference. In the insights, include near-term datathat will impact prescribing or launch plans, longer-term emerging targetswith promising data (include clinical endpoints and design that may impactongoing programs), and key competitors that directly impact companystrategy. Within four weeks of the conference, distribute a full report of theconference with detail on sessions of high strategic or tactical importance.

The final deliverable is the full conference report that includes anexpanded Executive Summary and detailed coverage of high-impactindividual sessions. The Executive Summary is designed for keyleadership positions and includes up to fifteen key points (segmented bynear versus long-term competition), as well as the strategic and tacticalrecommendations.

For each key finding, note the implications of the data andrecommendations for how the organization / department can considerreacting to the trends. The body of final deliverable includes short write-ups of each covered session to share with the organization. This detailedinformation is especially helpful when drug development teams are

interested in efficacy and safety data or trial design information for selectcompounds or mechanisms.

We advise that the full, comprehensive report be finalized no laterthan 6 weeks after the end of the conference to ensure the findingsare still relevant.

ConclusionIT is increasingly difficult for established agents to maintain theircompetitive advantage in the face of a raft of new market entrants, and foremerging agents to demonstrate a competitive advantage in alreadysaturated markets. In the current environment, organizations cannot riskskipping conference surveillance because the magnitude of the task issignificant, because they are under-resourced, or because they lack thestandardization to effectively turn conference findings into actionablerecommendations.

Conference surveillance is an important form of commercial CI that, whendone well, delivers predictive information to help companies anticipatenew opportunities and threats and—most importantly—providesorganizations actionable information to develop winning strategies andtactics for launch and beyond.

Conference surveillance requires meaningful time commitment,before, during, and after conference completion. However, it is aworkflow crucial to a market leading, up-to-date strategy forproducts in development.

Artisan has helped numerous franchise and disease teams conductconference surveillance using the techniques and tips outlinedabove. The findings, insights, and strategic recommendations thatArtisan has developed using conference CI have helped drive thecommercial success of several products and portfolios.

For all key findings, it is especially important to capture and integratecomments from the discussant and Q&A portion of the sessions—thisinformation is not publically available and is of high value.

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We invite you to contact us to discuss how Artisan's insights can help your business succeed.

950 Winter Street, Suite 4250, Waltham, MA 02451Telephone: +1.781.221.5656

Email: [email protected]

ARTISAN provides strategic and quantitative analysis that helps our clients'leadership act decisively. We recognize that even the most quantitativeanalysis involves interpretation. Let our experienced leadership guide yourstrategic decisions and help you make the most of your businessopportunities

BRAD Payne is a Vice President for ArtisanHealthcare Consulting. Brad focuses on newproduct development, and advising clients onhow to optimize commercial outcomes for theirown pipeline. This includes new productplanning, product differentiation, go-to-launchplanning, and crafting strategicrecommendations from conference surveillance.He has lead and delivered >100 consultingengagements with established and emergingpharmaceutical, biotech, and medical devicecompanies, with projects spanning multipletherapeutic areas, including oncology, rarediseases, cardio-vascular, and vaccines.

Brad’s areas of expertise include:

n Building cross-functional alignment in new product development, allowing teams to prioritize their portfolio and move forward in development quickly and decisively

n Providing up-to-date insights to key questions that drive development decisions, supported by secondary and surveillance insights

n Clearly outlining the development pathway needed to ensure products are effectively differentiated at launch

Brad holds a BA (cum laude) in Economics fromHarvard University and an MBA from ArizonaState University.

[email protected]: 781-996-7338

About the author